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Evaluation of the Efficacy and Tolerability of an Exclusion Diet in Patients With Juvenile Idiopathic Arthritis (JIA-ED)

M

Meyer Children's Hospital IRCCS

Status

Enrolling

Conditions

Juvenile Idiopathic Arthritis (JIA)

Treatments

Dietary Supplement: complete, polymeric formula, fiber, lactose and gluten free

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The JIA-ED study is a pilot project. Based on experience in another inflammatory disease, a 4-week period was extrapolated as sufficient to assess the effectiveness of the experimental intervention. This observation is supported by literature data showing that, halfway through phase I of the CDED (Crohn Diseasse Exclusion Diet), it is already possible to identify a subset of patients with Crohn's disease who are responsive to the dietary treatment and who also have a higher likelihood of achieving clinical remission by the end of the first phase of the diet itself.

Enrollment

20 estimated patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Confirmed diagnosis of juvenile idiopathic arthritis (JIA) in the forms of enthesitis-related arthritis and oligoarticular forms according to the ILAR 2001 criteria (https://medicalcriteria.com/web/reujia/);
  • Age between 6 and 18 years (not yet 18);
  • Active disease of mild to moderate severity, assessed through the Juvenile - Arthritis Disease Activity Score (JADAS10) tool (Trincianti C. et al., American College Rheumatology, 2021);
  • For study groups 2 and 3: failure of ongoing pharmacological therapy at the time of screening, defined as a failure to achieve at least a 20% reduction in JADAS10 values after 3 months of initiating DMARD therapy or biologic medication, or if the disease is inactive on such therapy, a 20% increase in those values;
  • Signed informed consent.

Exclusion criteria

  • Patients requiring systemic immunosuppressive therapy for active uveitis;
  • Patients undergoing therapy with systemic corticosteroids (defined as prednisone equivalent >0.5 mg/kg for >7 days) or intra-articular corticosteroids in the 3 months prior to enrollment;
  • Patients with fecal calprotectin values > 250 mcg/g at the time of screening;
  • Use of antibiotics in the month prior to enrollment.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Standard of care
No Intervention group
Description:
In this arm patients of newly diagnosis, or who failed synthetic or biologic therapy will be treated with standard of care therapy and free diet
Intervention arm
Experimental group
Description:
In this arm patients of newly diagnosis, or who failed synthetic or biologic therapy will be treated with the Crohn Disease Exclusion Diet (CDED) plus partial enteral nutrition
Treatment:
Dietary Supplement: complete, polymeric formula, fiber, lactose and gluten free

Trial contacts and locations

1

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Central trial contact

Polo Lionetti, MD, PhD, Ordinary Professor

Data sourced from clinicaltrials.gov

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